Category Archives: Drug Policy

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House Passes 12 Bills Aimed at Combating Opioid Crisis

On Tuesday, the House of Representatives passed a fleet of bills aimed at combating the ongoing opioid crisis, most aimed at developing preventative measures to curb opioid addiction by funding research. The measures passed with overwhelming bipartisan support. Key points of these legislative initiatives are summarized below. Quarles & Brady will continue to monitor their … Continue Reading

Federal Judge Overturns DEA’s Immediate Suspension Order…for now.

A United States District Court Judge issued a temporary restraining order prohibiting the Drug Enforcement Administration (DEA) from enforcing the Immediate Suspension Order issued against Morris & Dickson. Acknowledging, that the entire administrative record was not before the court, Judge Foote nonetheless held that “Plaintiff has demonstrated a substantial likelihood that it will be able … Continue Reading

Alleged Failure to Report Suspicious Orders Leads to Suspension

On May 2, 2018, the DEA issued an Order to Show Cause and Immediate Suspension of Registration (the “Order”) against Morris & Dickson Co., LLC (“M&D”), a drug distributor based in Louisiana with pharmacy customers in 7 states. The DEA has two main allegations against M&D: M&D failed to maintain effective controls against division of … Continue Reading

DEA Proposes Changes to Quota Regulations

On April 19, 2018, the Drug Enforcement Administration (DEA) issued a Notice of Proposed Rule Making (NPRM) proposing various changes to DEA’s process for setting Aggregate Production Quotas (APQ) and Individual Procurement Quotas (IPQ). Here are some of the more significant “changes” proposed in the NPRM: Aggregate Production Quotas DEA must consider the diversion of a … Continue Reading

DEA Gives Wholesalers Access to Some ARCOS Data, but Not Quantities Purchased

The DEA issued a short press release yesterday that, at first glance, appeared to deliver on something that wholesale drug distributors have been seeking for years—access to ARCOS data so that wholesalers can see the total number of controlled substances a customer is ordering.* Despite the sensational headline, the new DEA tool is underwhelming and … Continue Reading

Be Careful What You Wish For:  DEA to Update Suspicious Order Reporting Regulations

In a recently issued Request for Proposal (RFP) for Information Technology (IT) and other services in support of the Diversion Control Division, DEA indicated that it will be creating a new section in the Code of Federal Regulations. 21 C.F.R. 1301.78, will contain the suspicious order reporting requirement that is currently found in 21 C.F.R. … Continue Reading

Bipartisan Agreement that News Reports Regarding the Ensuring Patient Access and Effective Drug Enforcement Act are Light on Facts

On December 12, 2017, the Senate Judiciary Committee held an oversight hearing to discuss the Ensuring Patient Access and Effective Drug Enforcement Act (the “Act”). The Act has been the subject of recent sensationalized news reports which included interviews with a purported DEA whistleblower and other former DEA employees.… Continue Reading

An “Open Letter” to President Trump Regarding the Prescription Drug Abuse Epidemic

Dear President Trump, For several years the prescription drug epidemic has ravaged communities across the United States. During that time, the Drug Enforcement Administration (“DEA”) has aggressively pursued enforcement actions against the regulated industry. Despite admirable efforts to curtail the epidemic through enforcement actions, prescription drug abuse continues to be a public health crisis. There … Continue Reading

The Other Side of the Story: DEA Enforcement in the Opioid Crisis

Nobody would argue with the fact that there is an opioid crisis in our country – it is a demonstrable fact. However, there has recently been a significant focus on whether drug wholesalers and their business partners including lobbyists have caused people to die from overdoses, including a recent segment by 60 Minutes. While the … Continue Reading

West Virginia Imposes New Suspicious Order Reporting Requirements

The West Virginia Board of Pharmacy (“Board”) rolled out a new mandatory suspicious order reporting form for wholesalers at its board meeting last month.  The one-page form is designed to be filled out for each individual suspicious order being reported. This will require wholesalers that currently create and submit automated suspicious order reports to adapt … Continue Reading

DEA Prevails Over Masters Pharmaceutical, Inc.

On June 30, 2017, the Court of Appeals for the D.C. Circuit issued an order in Masters Pharmaceutical, Inc. v. Drug Enforcement Administration (No. 15-1335). In sum, the Court denied Masters Pharmaceutical, Inc.’s (“Masters”) Petition for Review seeking to overturn the Drug Enforcement Administration’s (“DEA”) revocation of Masters’ DEA registration. This decision has wide-ranging implications … Continue Reading

Oregon Adds Suspicious Order Reporting to Wholesale Distributor Requirements

Recently, the Oregon Board of Pharmacy adopted a new rule for wholesale distributors, requiring that they report suspicious orders to the Board for review. The rule goes into effect on July 1, 2017. The adoption of the new rule followed several recent settlements by wholesale distributors around the country, who are facing severe penalties for … Continue Reading

DEA Decisions: In the Matter of Wesley Pope, M.D.

An Oklahoma doctor wrote 19 Schedule II controlled substance prescriptions for a patient with low back pain over eight months without thoroughly documenting the patient’s history, confronting the patient over aberrant drug tests, or talking to other doctors who were prescribing the patient controlled substances. The Chief Administrative Law Judge felt the doctor should be … Continue Reading

Surgeon General Seeks Support from Doctors to End Opioid Epidemic

Last week, the U.S. Surgeon General, Dr. Vivek H. Murthy, sent a letter to 2.3 million American health professionals asking them to lead a national movement to “turn the tide” on the nation’s prescription opioid epidemic.  After visiting communities hardest hit by the opioid epidemic, Dr. Murthy’s appeal to clinicians was personal:   “Everywhere I … Continue Reading

DEA Will Not Reschedule Marijuana

  Marijuana is less dangerous than some substances in other schedules, but it will stay in Schedule I for now, DEA said Thursday. The agency also said that it supports marijuana research, is developing an online application system to apply for Schedule I research registrations, and will allow more manufacturers to grow marijuana for research. … Continue Reading

Improving Regulatory Transparency for New Medical Therapies Act Heading to the President as Amended by the Senate

On November 16, 2015, the House of Representatives agreed to the Senate’s amended version of the Improving Regulatory Transparency for New Medical Therapies Act (H.R. 639). We previously described how the version of H.R. 639 originally passed by the House gave manufacturers clarity and security on the timing of DEA actions related to the entrance of … Continue Reading

DEA Releases 2015 National Drug Threat Assessment Summary

On November 4, 2015, DEA Acting Administrator Chuck Rosenberg announced the results of the 2015 National Drug Threat Assessment Summary (NDTA). In addition to reporting in-depth findings regarding the availability and use of nine drugs of abuse, the 2015 NDTA focuses on the increasing threat of transnational criminal organizations (“TCOs”), confirming Michelle Leonhart’s testimony before … Continue Reading

Amendment to CSA Closer to Becoming Law

DEA Chronicles welcomes guest blogger Julia Hudson, a Q&B Health Law attorney. On September 30, 2015, the Improving Regulatory Transparency for New Medical Therapies Act moved one step closer to becoming federal law by passing the Senate Health, Education, Labor and Pensions Committee.  The bill, which was introduced on February 2, 2015 and passed in the House on … Continue Reading

GAO Issues Another Report Involving DEA

On July 27, 2015, the Government Accountability Office (GAO) released a report titled, Prescription Drugs: More DEA Information about Registrants’ Controlled Substances Roles Could Improve Their Understanding and Help Ensure Access.  GAO’s report examined, (1) to what extent registrants interact with DEA about their CSA responsibilities, and registrants’ perspectives on those interactions, (2) how state … Continue Reading

DEA to Continue Take Back Programs

On September 23, 2014, DEA announced that its ninth Take Back Day would be the agency’s last.  The announcement was made shortly after DEA published the Final Rule implementing the Secure and Responsible Drug Disposal Act of 2010.  The regulations promulgated by DEA allow “authorized collectors” the opportunity to receive and securely dispose of prescription … Continue Reading

DEA Announces Major Enforcement Action

On May 20, 2015, DEA issued a press release regarding a recent major enforcement action in Arkansas, Alabama, Louisiana, and Mississippi. Operation Pilluted targeted alleged pill mills that were engaged in the illegal distribution of oxycodone, hydrocodone and Xanax. The operation resulted in the arrest of 280 individuals, including 22 doctors and pharmacists. Executing 21 search … Continue Reading

Senate Committee Questions DEA on Quota Process

On May 5, 2015, the United States Senate, Caucus on International Narcotics Control held a hearing exploring the findings and recommendations of a Government Accountability Office investigation into the Drug Enforcement Administration’s management of its quota process.  The hearing, called by Senators Grassley and Feinstein, sought to explore the connection between DEA’s quota process and … Continue Reading
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